Remove COVID-19 Vaccine Remove FDA Remove Informed Consent
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Remember the Babies: The Need for Off-Label Pediatric Use of COVID-19 Vaccines

Bill of Health

Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set. The CDC, through its vaccine provider agreements, prevents physicians and parents from pursuing off-label use of COVID-19 vaccinations in young children.

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Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

Bill of Health

When news broke last week that Pfizer-BioNTech was submitting for Emergency Use Authorization (EUA) a two-dose COVID vaccine regimen for children under 5 to the U.S. Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time. Solutions for the Future.

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Can Children Consent to the COVID Vaccine? The Case of Foster Care and Juvenile Justice

Bill of Health

Despite pediatric COVID-19 vaccine availability, many youth remain unvaccinated , and are thus at higher risk of life-altering outcomes as a result of contracting COVID-19. [1]. Specific to the COVID-19 vaccine, children under age 18 in most jurisdictions will require parental consent. [8].

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Health Care Is Front and Center as DeSantis and Newsom Go Mano a Mano

Kaiser Health News

From abortion to covid-19 vaccines, Newsom and DeSantis could not be further apart. Transgender Care Florida Under DeSantis, Florida passed a law this year banning gender-affirming health care for trans minors and mandating that adult patients sign informed consent forms before starting or continuing hormone treatment.

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Tear Down the Goalposts – Rutgers Wins

Drug & Device Law

15, 2024) (“ CHD ”), the Third Circuit affirmed the right of a publicly supported university to require COVID-19 vaccination as a prerequisite to its students’ in-person attendance. First of all, only one of the plaintiffs ever sought vaccination, so the rest were never entitled to informed consent at any time.

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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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